(300 days)
The Vios CSM/CS Software is indicated for use by healthcare professionals for the purpose of centralized monitoring of patient data within a healthcare facility. The Vios CSM/CS SW receives, stores, manages, and displays patient physiological and waveform data and alarms generated by Vios proprietary patient vitals monitoring software.
The Vios CS SW enables the Vios Monitoring System to be used in networked mode within a healthcare IT network and runs on commercial IT equipment. The Vios CS SW operates as a communications hub that can pass the data generated by Vios proprietary vitals monitoring software to one or more remote viewing software applications, without modifying the data. The Vios CSM SW is the remote viewing software of the Model 2050 system. It allows up to 16 devices to be displayed on one screen and runs on a commercial IT device that satisfies defined Vios-defined technical specifications.
The provided text does not contain information about the acceptance criteria and study proving device performance for Vios Central Station Monitor/Central Server Software Model 2050. The document is an FDA 510(k) clearance letter and summary, which confirms substantial equivalence to a predicate device but does not detail specific performance studies with acceptance criteria, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot fulfill your request for the detailed performance information based on the provided input.
§ 870.2450 Medical cathode-ray tube display.
(a)
Identification. A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.(b)
Classification. Class II (performance standards).